EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
[…](2024) XXX  draft  
ANNEXES 1 to 2  
 
ANNEXES  
to the  
Commission Delegated Regulation  
amending Regulation (EU) of the European Parliament and of the Council as regards 
biodegradability criteria for coating agents and water retention polymers   EN 1  EN ANNEX  I 
 
Part II, section ‘CMC 9: POLYMERS OTHER THAN NUTRIENT POLYMERS’ , of Annex 
II to Regulation (EU) 2019/1009 is amended as follows:  
(1) in point 1, the introductory wording is replaced by the following:  
‘An EU fertilising product may contain polymers the purpose of which is:’;  
(2) point 2 is replaced by the following:  
‘2. From  17 October 2028, the polymers referred to in point 1(a) and (b) shall be:  
(a) polymers that are the result of a polymerisation process that has taken place in 
nature, independently of the process through which they have been extracted 
and which are not chemically modified substances within the meaning of 
Article  3, point (40), of Regulation (EC) No  1907/2006; or  
(b) polymers that are biodegradable in accordance with the criteria set out in 
Appendix 1 to this Annex. ’;  
(3) the following Appendi x 1 is added:  
‘Appendix 1  
Biodegradability criteria for polymers referred to in section CMC 9, point 1(a) and (b)  
1. The biodegradability of polymers referred to in section CMC 9, point 1(a) and (b) 
shall be demonstrated in the following environmental compartments:  
(a) Compartment  1: soi l; and  
(b) Compartment  2: fresh, estuarine or marine water.  
2. The polymer shall achieve:  
(a) in compartment 1:  
i. ultimate degradation of at least 90  % relative to the degradation of the 
reference material within 48 months plus the functionality period  (FP) as 
indicat ed on the label; or  
ii. mineralisation of at least 90  %, measured as evolved CO 2, over a maximum 
of 48 months plus the functionality period (FP) as indicated on the label ; 
(b) in compartment 2, ultimate degradation relative to the degradation of the reference 
mate rial in 12 months as set out in the Table below : 
Table : Pass criteria  for targeted degradation in Compartment 2   
Criterion 
assessed  Pass 
criterion  
(FP=0)  Pass 
criterion  
(FP=1 
month)  Pass 
criterion  
(FP=2 
months)  Pass 
criterion  
(FP=3 
months)  Pass 
criterion  
(FP≥6 
months)  Pass 
criterion  
(FP=9 
months)  
Minimum target 
degradation 
after 12 months  ≥ 43,8 %  ≥ 41,0 %  ≥ 38,1 %  ≥ 35,1 %  ≥ 25,0 %  ≥ 13,4 EN 2  EN For functionality periods of less than 6 months , other than the ones set out in the 
Table,  the pass criteria shall be calculated using the following exponential decay 
formula : 
TD12m=  1-exp(- λ *(12 -FP) 
where:  
TD12m  the minimum target degradation after 12 months  (expressed as a 
percentage)  
λ  the degradation rate calculated as λ = -ln (0,1)  / t90 
t90   the time for 90% biodegradation , which is 48 months  
FP   the functionality period  (expressed in months)  
 
3. To demonstrate the biodegradability criteria in point 2(a), one  of the following test 
methods shall be used:  
(a) EN ISO 17556:2019. Plastics – Dete rmination of the ultimate aerobic 
biodegradability of plastic materials in soil by measuring the oxygen demand in a 
respirometer or the amount of carbon dioxide evolved;  
(b) ASTM D5988 -96:2018. Standard Test Method for Determining Aerobic 
Biodegradation in So il of Plastic Materials.  
4. When  there is no phase transition (glass transition or melting transition) between 
25°C and 37°C, the temperature during testing in accordance with points 3(a) or (b) 
may be adjusted at 37oC.  
In such a case, the relevant criteri on in point 2(a) shall be considered as being 
demonstrated if the polymer achieve s:  
(a) at least 45  % ultimate degradation or minerali sation as referred to in point 2(a) in a 
separate test at 25°C in 20 months, whereby degradation  or minerali sation shall be 
progressing, and the plateau phase shall not have been reached, unless  the 
degradation or minerali sation is at least 90  %; and   
(b) ultimate degradation of at least 90  % relative to degradation of the reference material 
within 20 months plus the functionality period as indicated on the label; or  
(c) mineralisation of at least 90  %, measured as evolved CO 2, over a maximum of 20 
months plus the functionality period as indicated on the label.  
5. To demonstrate the biodegradability criteria in point 2(b), one of the foll owing test 
methods shall be used:  
(a) EN/ISO 14851:2019 Determination of the ultimate aerobic biodegradability of 
plastic materials in an aqueous medium. Method by measuring the oxygen demand in 
a closed respirometer;  
(b) EN/ISO 14852:2021. Determination of the ul timate aerobic biodegradability of 
plastic materials in an aqueous medium. Method by analysis of evolved carbon 
dioxide;  
(c) ASTM D6691:2018 Standard Test Method for Determining Aerobic Biodegradation 
of Plastic Materials in the Marine Environment by a Define d Microbial Consortium 
or Natural Sea Water Inoculum.  EN 3  EN 6. For polymers referred to in section CMC 9, point 1(a), the test shall be performed on 
a material consisting of:  
(a) the polymer or polymers contained in or building a continuous coating on particles 
(‘poly mer particles’) comparable in terms of composition, form, size and surface area 
to the coating agent present in the EU fertilising product;  
(b) the isolated coating; or 
(c) the polymer  or the polymers  in the form placed on the market where the core of the 
material is replaced by an inert material such as glass.  
7. For polymers referred to in section CMC 9, point 1(b), the test shall be performed on 
a material consisting of the polymer in the form placed on the market.  
8. The following materials may be used as reference materials:  
(a) positive controls: biodegradable materials such as micro -crystalline cellulose 
powder, ashless cellulose filters or poly -β-hydroxybutyrate;  
(b) negative controls: non -biodegradable poly mers such as polyethylene or 
polystyrene. ’.  EN 4  EN ANNEX  II 
Part I  of Annex III to Regulation (EU) 2019/1009  is amended as follows:   
(1) in point 1, subpoint (f) is replaced by the following:  
‘(f) for products containing a polymer referred to in Part II, section CMC 9, point 1(a) or (b), 
of Annex II : 
(i) the time period following use during which the nutrient release is being controlled or the 
water retention capacity is being increased (the ‘functional ity period’), which shall not be 
longer than the period between two applications in accordance with the use instructions 
referred to in point (d) of this point;  
(ii) an instruction not to apply the product within at least 3 meters of surface water bodies, 
while respecting any national rules setting more stringent requirements; ’; 
(2) point 7 is replaced by the following:   
‘7. The end -user shall be instructed not to use the product in contact with soil, and in 
collaboration with the manufacturer, to make sure of a sound disposal of the product after end 
of use where the EU fertilising product:    
a. is a growing medium as referred to in Part II, section PFC 4, point 2a, of 
Annex I;    
b. contains a polymer with the purpose of binding material in the product as 
referred to  in Part II, section CMC 9, point 1(c) of Annex II, which does not meet any 
of the requirements in Part II, section CMC 1, point 1(f)(i), (ii) , or (iii) or (iv)  of  that 
Annex.’.